PREPOPIK Drug Patent Profile

Which patents cover Prepopik, and when can generic versions of Prepopik launch?

Prepopik is a drug marketed by Ferring Pharms Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-two patent family members in twenty-five countries.

The generic ingredient in PREPOPIK is citric acid; magnesium oxide; sodium picosulfate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the citric acid; magnesium oxide; sodium picosulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Prepopik

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (citric acid; magnesium oxide; sodium picosulfate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for PREPOPIK

International Patents:	32
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
Drug Prices:	Drug price information for PREPOPIK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PREPOPIK
DailyMed Link:	PREPOPIK at DailyMed

See drug prices for PREPOPIK

See drug sales revenues for PREPOPIK

Recent Clinical Trials for PREPOPIK

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Ferring Pharmaceuticals	Phase 4
The Cleveland Clinic	Phase 4
Ferring Pharmaceuticals	Phase 3

See all PREPOPIK clinical trials

Paragraph IV (Patent) Challenges for PREPOPIK

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PREPOPIK	Oral Solution	citric acid; magnesium oxide; sodium picosulfate	10 mg, 3.5 g, and 12 g	202535	1	2014-05-21

US Patents and Regulatory Information for PREPOPIK

PREPOPIK is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ferring Pharms Inc	PREPOPIK	citric acid; magnesium oxide; sodium picosulfate	FOR SOLUTION;ORAL	202535-001	Jul 16, 2012		DISCN	Yes	No	8,450,338		Y
Ferring Pharms Inc	PREPOPIK	citric acid; magnesium oxide; sodium picosulfate	FOR SOLUTION;ORAL	202535-001	Jul 16, 2012		DISCN	Yes	No	8,481,083		Y

International Patents for PREPOPIK

When does loss-of-exclusivity occur for PREPOPIK?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Denmark

European Patent Office

Hungary

Israel

Japan

Jordan

Lithuania

Mexico

New Zealand

Poland

Portugal

Russian Federation

Saudi Arabia

Slovenia

South Africa

South Korea

Spain

Taiwan

United Kingdom

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PREPOPIK around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	101330096
Israel	204500	תהליך לייצור הרכב או הרכב רוקחי על ידי ריסוס ציפוי של שכבת נתרן פיקוסולפאט על גרעין של אשלגן ביקרבונאט (Process for the manufacture of a composition or pharmaceutical composition comprising spray coating a layer of sodium picosulphate on a core of potassium bicarbonate)
Slovenia	2207526
China	101820859
World Intellectual Property Organization (WIPO)	2009047633

PREPOPIK: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

PREPOPIK (Alosetron Hydrochloride) is a selective serotonin 5-HT3 receptor antagonist approved for the treatment of severe diarrhea-predominant irritable bowel syndrome (IBS-D) in women. Market entry and subsequent performance are shaped by regulatory restrictions, therapeutic competition, and patient access.

What is PREPOPIK's Regulatory History and Current Status?

Alosetron hydrochloride, the active pharmaceutical ingredient in PREPOPIK, was initially approved by the U.S. Food and Drug Administration (FDA) in June 2000 for severe IBS-D. Its marketing was voluntarily withdrawn by GlaxoSmithKline (GSK) in November 2000 due to concerns regarding serious gastrointestinal adverse events, including ischemic colitis and severe constipation.

Following a comprehensive review, including data from observational studies and post-marketing surveillance, the FDA re-approved alosetron hydrochloride in June 2002 under a strict Risk Management Program (RMP) known as the Risk Evaluation and Mitigation Strategy (REMS). This REMS program is a critical factor defining PREPOPIK's market access and prescribing practices.

The REMS program mandates that healthcare providers prescribing alosetron hydrochloride must be certified. Patients initiating treatment must also acknowledge the risks and sign a patient-physician agreement. This controlled access limits the prescriber base and patient population, impacting market penetration compared to less restricted medications.

Key REMS Program Components:

• Healthcare Provider Certification: Prescribers must complete a training program and be certified by the manufacturer.
• Patient-Physician Agreement: Patients must be informed of the risks and benefits and sign an agreement confirming understanding.
• Limited Distribution: The drug is available only through pharmacies participating in the REMS program.
• Contraindications: The drug is contraindicated in patients with constipation or evidence of intestinal obstruction.

Source: FDA [1]

Who are PREPOPIK's Primary Competitors?

The therapeutic landscape for IBS-D is characterized by a multi-faceted approach, with PREPOPIK competing against drugs with different mechanisms of action and risk profiles.

Direct Competitors (Serotonin Receptor Antagonists):

• Ondansetron: While not specifically approved for IBS-D, ondansetron is a 5-HT3 antagonist sometimes used off-label. However, its broader applications and different safety profile differentiate it from PREPOPIK's targeted indication and REMS.

Indirect Competitors (Other IBS-D Treatments):

• Antispasmodics: Medications like dicyclomine and hyoscyamine are used to alleviate abdominal pain and cramping associated with IBS.
• Antidiarrheals: Loperamide, an opioid agonist, is commonly used for symptomatic relief of diarrhea. Its over-the-counter availability and different mechanism of action position it as a competitor for less severe cases or as a first-line option.
• Bile Acid Sequestrants: Cholestyramine and colestipol can be effective in some patients with IBS-D, particularly those with malabsorption of bile acids.
• Antidepressants (Low-Dose TCAs and SSRIs): Tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs), when used at low doses, can modulate gut-brain signaling and influence gut motility and pain perception in IBS patients.
• Newer Agents:
  • Rifaximin (Xifaxan): Approved for IBS-D associated with prior diarrhea caused by traveler's diarrhea and for reducing the risk of overt hepatic encephalopathy. Its mechanism involves altering gut microbiota.
  • Eluxadoline (Viberzi): A mixed mu-opioid receptor agonist and delta-opioid receptor antagonist, approved for IBS-D. It directly impacts gut motility and secretion.
  • Diphenoxylate/Atropine (Lomotil): Another opioid-based antidiarrheal, subject to prescription requirements.

The presence of these diverse therapeutic options, each with varying efficacy, safety profiles, and accessibility, means PREPOPIK competes not only based on its direct pharmacological effects but also on the strict REMS program that limits its use.

What is PREPOPIK's Market Performance and Financial Trajectory?

PREPOPIK's market performance has been constrained by its REMS program. Sales figures reflect a niche market segment for patients with severe IBS-D who have not responded to other treatments and can tolerate the associated risks under strict medical supervision.

Sales Data and Trends:

Data on PREPOPIK's specific sales are often aggregated within broader GlaxoSmithKline (GSK) gastrointestinal portfolios or listed under "other" revenue streams in financial reports, making precise, independent revenue figures challenging to isolate. However, general market observations and available reports indicate:

• Limited Market Share: Due to the REMS, PREPOPIK has a significantly smaller market share compared to more broadly accessible IBS-D treatments.
• Niche Patient Population: The drug targets a subset of patients with severe, refractory IBS-D, indicating a controlled and specific demand.
• Consistent, Low-Volume Sales: Prescription data and market analyses suggest a consistent, albeit low-volume, prescription rate, driven by the established, certified prescriber base.
• No Significant Growth Surge Expected: The REMS program inherently limits significant market expansion. Future financial trajectory is likely to be characterized by stability rather than aggressive growth, barring any changes to the regulatory framework or significant breakthroughs in alternative IBS-D treatments that might indirectly affect PREPOPIK's positioning.

Financial Impact Considerations:

• Revenue Generation: Revenue is directly tied to the number of patients eligible for and prescribed PREPOPIK under the REMS. Pricing strategies aim to optimize revenue within this limited patient pool.
• Manufacturing and Distribution Costs: Maintaining compliance with the REMS program incurs ongoing costs for manufacturing, distribution, training, and monitoring.
• R&D Investment: Further significant investment in the development of PREPOPIK itself is unlikely, given its mature stage in the product lifecycle and the established regulatory hurdles. Future R&D within the IBS space for GSK would likely focus on new molecular entities or different therapeutic approaches.

Precise revenue figures for PREPOPIK are not publicly broken out by GSK in their annual financial reports. However, it is understood to be a small contributor to the company's overall gastrointestinal segment revenue. For instance, in GSK's 2022 annual report, the gastrointestinal category accounted for £3.0 billion in revenue, with specific drug contributions not individually itemized for PREPOPIK. [2]

What are the Key Challenges and Opportunities for PREPOPIK?

PREPOPIK operates within a challenging regulatory environment, presenting both significant limitations and specific market opportunities.

Key Challenges:

• REMS Program Burden: The stringent REMS program creates a substantial barrier to access for both prescribers and patients, limiting its potential market size and ease of use. This complexity discourages broader adoption and requires significant logistical effort for compliance.
• Serious Adverse Event Profile: The history of serious gastrointestinal side effects, including ischemic colitis and severe constipation, necessitates careful patient selection and continuous monitoring, contributing to the restrictive prescribing practices.
• Therapeutic Alternatives: The availability of a wide range of alternative treatments for IBS-D, including both established and newer agents with potentially more favorable safety profiles or simpler administration, provides patients and physicians with choices that do not involve the REMS program.
• Physician Education and Awareness: Ensuring that the limited pool of certified physicians remains aware of PREPOPIK's role and appropriate patient selection criteria is an ongoing challenge.

Key Opportunities:

• Unmet Need in Severe IBS-D: For a specific sub-population of patients with severe IBS-D who have failed multiple other therapies and can be managed within the REMS framework, PREPOPIK offers a targeted treatment option that may provide significant symptom relief where others have not.
• Physician Loyalty within Niche: Certified prescribers who have successfully used PREPOPIK and understand its risk-benefit profile for their patients may exhibit strong loyalty, ensuring a stable, albeit small, prescription base.
• Potential for Lifecycle Management: While significant R&D is unlikely, opportunities might exist in exploring improved formulations or combination therapies, provided they can navigate regulatory pathways without exacerbating the existing risk profile. However, this is a low-probability scenario.
• Market Stability: In its current niche, PREPOPIK offers a degree of market stability due to its unique position as a restricted, highly targeted therapy. It is less susceptible to the rapid shifts in market share seen with drugs facing direct, broad competition.

What is the Outlook for PREPOPIK?

The future outlook for PREPOPIK is characterized by a stable, albeit limited, market presence. Its trajectory is intrinsically linked to the continued necessity of its specific therapeutic action within the severe IBS-D patient population that can be managed under its REMS program.

Factors Influencing Future Outlook:

• Regulatory Oversight: Any future changes to the FDA's REMS requirements for alosetron hydrochloride would fundamentally alter its market access and trajectory. However, given the drug's history, significant relaxation of these controls is improbable without substantial new safety data or evolving regulatory paradigms.
• Competitive Landscape Evolution: The development of novel IBS-D treatments with superior efficacy, improved safety profiles, or simpler administration could further diminish PREPOPIK's market share. Conversely, a lack of innovation in severe IBS-D refractory cases could maintain its niche utility.
• Patient Demographics and Disease Prevalence: Changes in the prevalence of severe IBS-D and the demographic characteristics of affected individuals could indirectly influence demand, but PREPOPIK’s access limitations will remain the primary determinant.
• Manufacturer Strategy: GlaxoSmithKline’s strategic decisions regarding the commercialization and support of PREPOPIK, including marketing to the certified prescriber base, will impact its ongoing market performance.

Projected Trajectory:

PREPOPIK is projected to maintain its position as a niche therapy for severe IBS-D. Its financial trajectory will likely remain stable, reflecting consistent demand from a carefully managed patient population. Significant growth is not anticipated. The drug's long-term viability is dependent on its continued effectiveness for its targeted patient group and the sustained regulatory framework that permits its restricted use.

Key Takeaways

• PREPOPIK (Alosetron Hydrochloride) is approved for severe diarrhea-predominant irritable bowel syndrome (IBS-D) in women.
• Its market access is strictly controlled by a U.S. Food and Drug Administration (FDA) Risk Management Program (REMS), mandating prescriber certification and patient agreements due to serious gastrointestinal side effect concerns.
• PREPOPIK faces competition from a range of IBS-D treatments, including antispasmodics, antidiarrheals, bile acid sequestrants, antidepressants, rifaximin, and eluxadoline.
• Precise sales data for PREPOPIK is not publicly disclosed by its manufacturer, GlaxoSmithKline (GSK), but it represents a niche market segment.
• The REMS program poses a significant challenge by limiting market size and accessibility, while its targeted efficacy for severe, refractory IBS-D represents a key opportunity for its defined patient population.
• The future outlook for PREPOPIK is one of market stability, with significant growth unlikely unless regulatory controls are altered or the competitive landscape shifts dramatically.

Frequently Asked Questions

1. What are the primary contraindications for PREPOPIK? PREPOPIK is contraindicated in patients who are constipated or have any evidence of intestinal obstruction. [1]

2. Does PREPOPIK require a special prescription process? Yes, PREPOPIK can only be prescribed by healthcare providers who are certified under the drug's REMS program. Patients must also sign a patient-physician agreement. [1]

3. What are the most serious adverse events associated with PREPOPIK? The most serious adverse events associated with PREPOPIK include ischemic colitis and severe, potentially life-threatening constipation. [1]

4. Can PREPOPIK be used for all types of Irritable Bowel Syndrome? No, PREPOPIK is specifically approved for the treatment of severe diarrhea-predominant IBS (IBS-D) in women for whom inadequate symptom control has been achieved with conventional therapy.

5. How is PREPOPIK's market performance measured given its limited access? PREPOPIK's market performance is measured by its prescription volume within the certified prescriber and patient population, which is tracked through pharmaceutical data providers and internal manufacturer sales reports. Its value is derived from serving a specific, unmet need in a tightly controlled segment.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Alosetron hydrochloride. Retrieved from [FDA's Alosetron Hydrochloride Information Page - specific URL may vary, access via FDA.gov search for "alosetron hydrochloride REMS"]

[2] GlaxoSmithKline. (2023). Annual Report and Accounts 2022. Retrieved from [GSK's Investor Relations website - specific URL for 2022 Annual Report]